title: Weight management for individuals with intellectual and developmental disabilities: rationale and design for an 18 month randomized trial.
abstract: Weight management for individuals with intellectual and developmental disabilities (IDD) has received limited attention. Studies on weight management in this population have been conducted over short time frames, in small samples with inadequate statistical power, infrequently used a randomized design, and have not evaluated the use of emerging effective dietary strategies such as pre-packaged meals (PMs). Low energy/fat PMs may be useful in individuals with IDD as they simplify meal planning, limit undesirable food choices, teach appropriate portion sizes, are convenient and easy to prepare, and when combined with fruits and vegetables provide a high volume, low energy dense meal. A randomized effectiveness trial will be conducted in 150 overweight/obese adults with mild to moderate IDD, and their study partners to compare weight loss (6 months) and weight maintenance (12 months) between 2 weight management approaches: 1. A Stop Light Diet enhanced with reduced energy/fat PMs (eSLD); and 2. A recommended care reduced energy/fat meal plan diet (RC). The primary aim is to compare weight loss (0-6 months) and weight maintenance (7-18 months) between the eSLD and RC diets. Secondarily, changes in chronic disease risk factors between the eSLD and RC diets including blood pressure, glucose, insulin, LDL-cholesterol, and HDL-cholesterol will be compared during both weight loss and weight maintenance. Finally, potential mediators of weight loss including energy intake, physical activity, data recording, adherence to the diet, study partner self-efficacy and daily stress related to dietary change will be explored.
authors.affiliation: Cardiovascular Research Institute, Division of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS 66160, USA. jdonnelly@ku.edu
authors.forename: J E
authors.initials: JE
authors.lastname: Donnelly
authors.forename: R R
authors.initials: RR
authors.lastname: Saunders
authors.forename: M
authors.initials: M
authors.lastname: Saunders
authors.forename: R A
authors.initials: RA
authors.lastname: Washburn
authors.forename: D K
authors.initials: DK
authors.lastname: Sullivan
authors.forename: C A
authors.initials: CA
authors.lastname: Gibson
authors.forename: L T
authors.initials: LT
authors.lastname: Ptomey
authors.forename: J R
authors.initials: JR
authors.lastname: Goetz
authors.forename: J J
authors.initials: JJ
authors.lastname: Honas
authors.forename: J L
authors.initials: JL
authors.lastname: Betts
authors.forename: M R
authors.initials: MR
authors.lastname: Rondon
authors.forename: B K
authors.initials: BK
authors.lastname: Smith
authors.forename: M S
authors.initials: MS
authors.lastname: Mayo
mesh_terms: D061725:Accelerometry; D001786:Blood Glucose; D001794:Blood Pressure; D001835:Body Weight; D017028:Caregivers; D002658:Developmental Disabilities / Q000453:epidemiology*; D004038:Diet, Reducing / Q000379:methods*; D002149:Energy Intake; D015444:Exercise; D006801:Humans; D008607:Intellectual Disability / Q000453:epidemiology*; D008055:Lipids / Q000097:blood; D009765:Obesity / Q000178:diet therapy; D050177:Overweight / Q000178:diet therapy*; D010349:Patient Compliance; D017060:Patient Satisfaction; D012107:Research Design; D015431:Weight Loss
chemical_list: D001786:Blood Glucose; D008055:Lipids
keywords: IDD; Intellectual and developmental disability; PMs; Physical activity; Pre-packaged meals; RC; Stop Light Diet; Weight maintenance; Weight management; eSLD; enhanced Stop Light Diet; intellectual and developmental disabilities; pre-packaged meals; recommended care